Femhrt — Class III drug recall D-303-2013
Terminated recall by Warner Chilcott Company LLC, reported 2013-05-08, distributed nationwide. Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migr
| Recall number | D-303-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Warner Chilcott Company LLC, Fajardo, PR, United States |
| Recall initiated | 2013-02-15 |
| Classified | 2013-04-30 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 27,509 bottles |
| Reason classes | chemical contamination |
| NDC | 00430-0145-23 |
| Lot numbers | 04/13, 510122B |
Product
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Reason for recall
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-303-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.